Teva announces FDA filing acceptance for Ajovy (fremanezumab) in paediatric episodic migraine prevention

Teva Pharmaceuticals

7 April 2025 - If approved for an expanded paediatric indication, Ajovy would be the first calcitonin gene-related peptide antagonist for migraine prevention in adults and episodic migraine prevention in paediatric patients, addressing the high unmet need for effective treatments.

Teva Pharmaceuticals announced today that the US FDA has accepted its supplemental biologics license application for Ajovy (fremanezumab-vfrm) to expand the indication to include the prevention of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more.

Read Teva Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , US , Paediatrics , Dossier